Hepatitis CPhase 4STARNCT00502970
Short Course of Interferon Treatment in Patients With HCV Infection
A Phase 4 study testing 16 weeks Interferon Tiw with Ribavirin and 24 weeks Interferon in people with Hepatitis C and Chronic Disease, run by Aga Khan University at 1 site in Pakistan.
Trial summary
To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hepatitis C, Chronic Disease, Treatment
- What is being tested?
- 16 weeks Interferon Tiw with Ribavirin and 24 weeks Interferon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- May 2004to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult males and non-pregnant females (more than 18 and less than equal to 50 years of age).
- Treatment naïve patients.
- Serological evidence of hepatitis C infection by an anti-HCV antibody test
- HCV PCR positive
- Genotype 3
- Absence of cirrhosis on liver biopsy.
- Absence of alcohol or drug abuse.
Who cannot join
- Patients who do not consent to be included in the study.
- Pregnant or breast feeding females.
- Patients with a hemoglobin of <10g/dl, ANC <1500c/mm, and a platelet count <90000c/mm.
- Genotype non 3
- HCV PCR positive at the end of 4 weeks of treatment.
- Presence of cirrhosis on liver biopsy.
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- Decompensated liver disease.
- History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
- History of having received IFN, PEG-IFN, RBV therapy previously.
- History of systemic antiviral therapy or investigational drug 3 months prior to the first dose of study treatment.
- Patients expected to need systemic antiviral therapy at any time during their participation in the study.
- Exceptions from the last two exclusion criteria are patients who have had a limited (less than 7 day) course of acyclovir or valacyclovir for herpetic lesions more than 1 month prior to the first administration of trial treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing a Short Course Versus Standard Treatment in Patients With Chronic Hepatitis C Virus Infection
To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.
Read the detailed description
- INTRODUCTION 1.1 Hepatitis C Hepatitis C Virus (HCV) is a major cause of chronic hepatitis and hepatic fibrosis1. Acute infection advances to chronicity in up to 80% of patients, which can further progress to cirrhosis and hepatocellular carcinoma in a significant number1. Hepatitis C is a global problem, prevalent in industrialized as well as in the developing world2. It is a major cause of chronic liver disease (CLD) in Pakistan and has surpassed hepatitis B as the single most important cause for cirrhosis and hepatocellular carcinoma (HCC) in Pakistan 3. 1.2 Study Medications A combination of interferon and ribavirin therapy has been the standard of care world-wide for the past few years1, 2. Standard treatment duration is for 24 weeks for genotype non 1, and 48 weeks for genotype 12. 1.2.1 Interferon Alfa 2a Interferon Alfa was the first drug shown to have bioactivity against HCV. Combining ribavirin with interferon Alfa was found to be more effective than interferon Alfa mono-therapy in previously untreated patients as well in patients who relapsed after one or more courses of interferon Alfa therapy2. 1.2.2 Ribavirin Ribavirin is a guanosine analogue that inhibits the in vitro replication of a wide range of RNA and DNA viruses1. The mechanism of antiviral activity is not fully defined, although it may involve alteration of cellular nucleotide pools and inhibition of viral RNA synthesis1, 4. Ribavirin monotherapy has little or no effect on the replication of HCV but can result in normalization of serum ALT activity and improvement in liver histology. However, relapse occurs in nearly all patients treated with ribavirin alone1. Combining Ribavirin with Interferon has been found to be more effective than Interferon monotherapy in the treatment of chronic hepatitis C. In a large clinical trial of 1121 patients, a sustained virological response (SVR) was achieved in 53% of patients treated with Interferon plus Ribavirin as compared to 29% of patients treated with Interferon alone1, 4.
- RATIONALE Most treatment related studies on HCV have come from the West, where the most prevalent genotype is 1; their results however do not necessarily reflect the outcome in a developing country like Pakistan, where studies have already confirmed that the most prevalent genotype is 32. Success rates have globally been reported to be high when treating genotype 3: it has long been observed that patients infected with genotype 2 and 3 respond better to interferon therapy than patients infected with genotype 11, 3. Favorable prognostic factors have been identified which predict a better response to therapy in the treatment of chronic HCV. These include:
- Younger age
- Genotype 3
- No cirrhosis on liver biopsy, and
- Absence of alcohol or drug abuse1, 7. Few studies have investigated the efficacy of a short course therapy for patients with favorable predictive factors; most of these studies have used interferon monotherapy4, 5, while others have used a combination treatment for shorter duration in relapsed patients6. There is evidence that combination treatment may be beneficial when used as induction therapy, followed by interferon in a short course program, 7. Cases infected with HCV genotype 3 being treated for as little as 4-12 weeks and remaining sustained responders have been reported8 Since HCV genotype 3 responds so well to a combination of interferon and Ribavarin, it has been suggested that this patient population may have a similar response to a shorter duration of therapy7, 8, 9. The efficacy of a short course interferon and Ribavarin combination therapy compared to a longer course of therapy has not been compared in the treatment of patients with favorable predictive factors. 2.1 Rationale for Dosage Selection 1.2.2.1 Interferon Alfa 2a The dose chosen for interferon Alfa 2a (3 million units thrice weekly, sc) is the dose currently approved in Pakistan for combination therapy with ribavarin1. 1.2.2.2 Ribavarin The dose chosen for Ribavarin (800-1200 mg per day) is the dose currently approved in Pakistan for combination therapy with interferon in patients with HCV.1
- HYPOTHESIS In patients with chronic hepatitis C infection with favorable predictive factors for treatment, a short course of combination therapy with interferon and Ribavarin is equally efficacious as the longer course of treatment.
- OBJECTIVE To determine whether 16 weeks of interferon and Ribavarin therapy is as effective as 24 weeks of therapy in achieving sustained virological response in patients with favorable predictive factors who are infected with HCV genotype 3.
- SIGNIFICANCE Pakistan has an enormous burden of chronic HCV infection. The cost of treatment is prohibitive and is unaffordable for a large proportion of our population2, 3. A short course therapy comparable to the standard regimen would have significant implications; a striking decrease in financial burden on the health care system of the country, as well as the patients and a reduction in patient exposure to both medications, resulting in decreased treatment related adverse effects. In addition a larger number of patients will be able to afford the treatment due to a decrease in treatment duration and in turn the overall cost.
- Conditions
- Hepatitis C, Chronic Disease, Treatment
- Being tested
- 16 weeks Interferon Tiw with Ribavirin, 24 weeks Interferon
- Keywords
- Chronic HCV, Treatment
- Medical subject headings
- Hepatitis C, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 weeks Interferon Tiw with RibavirinDrug
Also called Uniferon
16 weeks Interferon Tiw
24 weeks InterferonDrug
Also called Uniferon
24 weeks Interferon Tiw with Ribavirin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 16 weeks Interferon Tiw with Ribavirin Receives: Drug: 16 weeks Interferon Tiw with Ribavirin |
| 2 | Active comparator | 24 weeks Interferon Tiw with Ribavirin Receives: Drug: 24 weeks Interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological response
Measured: six months after stopping treatment
Secondary outcomes (1)
Safety of short course of Interferon & Ribavirin
Measured: Four or Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startMay 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Getz Pharma
- Investigators
- Saeed S Hamid, FRCP, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502970
- Sponsor's protocol ID
- 302-Med/ERC-04
- Acronym
- STAR
- Status last verified
- Jan 2008
- First submitted
- 16 Jul 2007
- Last updated
- 11 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing a Short Course Versus Standard Treatment in Patients With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT00502970
- Acronym / sponsor ID
- STAR / 302-Med/ERC-04
- Conditions
- Hepatitis C, Chronic Disease, Treatment
- Keywords
- Chronic HCV, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Getz Pharma
- Study start
- May 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.
Detailed description
- INTRODUCTION 1.1 Hepatitis C Hepatitis C Virus (HCV) is a major cause of chronic hepatitis and hepatic fibrosis1. Acute infection advances to chronicity in up to 80% of patients, which can further progress to cirrhosis and hepatocellular carcinoma in a significant number1. Hepatitis C is a global problem, prevalent in industrialized as well as in the developing world2. It is a major cause of chronic liver disease (CLD) in Pakistan and has surpassed hepatitis B as the single most important cause for cirrhosis and hepatocellular carcinoma (HCC) in Pakistan 3. 1.2 Study Medications A combination of interferon and ribavirin therapy has been the standard of care world-wide for the past few years1, 2. Standard treatment duration is for 24 weeks for genotype non 1, and 48 weeks for genotype 12. 1.2.1 Interferon Alfa 2a Interferon Alfa was the first drug shown to have bioactivity against HCV. Combining ribavirin with interferon Alfa was found to be more effective than interferon Alfa mono-therapy in previously untreated patients as well in patients who relapsed after one or more courses of interferon Alfa therapy2. 1.2.2 Ribavirin Ribavirin is a guanosine analogue that inhibits the in vitro replication of a wide range of RNA and DNA viruses1. The mechanism of antiviral activity is not fully defined, although it may involve alteration of cellular nucleotide pools and inhibition of viral RNA synthesis1, 4. Ribavirin monotherapy has little or no effect on the replication of HCV but can result in normalization of serum ALT activity and improvement in liver histology. However, relapse occurs in nearly all patients treated with ribavirin alone1. Combining Ribavirin with Interferon has been found to be more effective than Interferon monotherapy in the treatment of chronic hepatitis C. In a large clinical trial of 1121 patients, a sustained virological response (SVR) was achieved in 53% of patients treated with Interferon plus Ribavirin as compared to 29% of patients treated with Interferon alone1, 4.
- RATIONALE Most treatment related studies on HCV have come from the West, where the most prevalent genotype is 1; their results however do not necessarily reflect the outcome in a developing country like Pakistan, where studies have already confirmed that the most prevalent genotype is 32. Success rates have globally been reported to be high when treating genotype 3: it has long been observed that patients infected with genotype 2 and 3 respond better to interferon therapy than patients infected with genotype 11, 3. Favorable prognostic factors have been identified which predict a better response to therapy in the treatment of chronic HCV. These include:
- Younger age
- Genotype 3
- No cirrhosis on liver biopsy, and
- Absence of alcohol or drug abuse1, 7. Few studies have investigated the efficacy of a short course therapy for patients with favorable predictive factors; most of these studies have used interferon monotherapy4, 5, while others have used a combination treatment for shorter duration in relapsed patients6. There is evidence that combination treatment may be beneficial when used as induction therapy, followed by interferon in a short course program, 7. Cases infected with HCV genotype 3 being treated for as little as 4-12 weeks and remaining sustained responders have been reported8 Since HCV genotype 3 responds so well to a combination of interferon and Ribavarin, it has been suggested that this patient population may have a similar response to a shorter duration of therapy7, 8, 9. The efficacy of a short course interferon and Ribavarin combination therapy compared to a longer course of therapy has not been compared in the treatment of patients with favorable predictive factors. 2.1 Rationale for Dosage Selection 1.2.2.1 Interferon Alfa 2a The dose chosen for interferon Alfa 2a (3 million units thrice weekly, sc) is the dose currently approved in Pakistan for combination therapy with ribavarin1. 1.2.2.2 Ribavarin The dose chosen for Ribavarin (800-1200 mg per day) is the dose currently approved in Pakistan for combination therapy with interferon in patients with HCV.1
- HYPOTHESIS In patients with chronic hepatitis C infection with favorable predictive factors for treatment, a short course of combination therapy with interferon and Ribavarin is equally efficacious as the longer course of treatment.
- OBJECTIVE To determine whether 16 weeks of interferon and Ribavarin therapy is as effective as 24 weeks of therapy in achieving sustained virological response in patients with favorable predictive factors who are infected with HCV genotype 3.
- SIGNIFICANCE Pakistan has an enormous burden of chronic HCV infection. The cost of treatment is prohibitive and is unaffordable for a large proportion of our population2, 3. A short course therapy comparable to the standard regimen would have significant implications; a striking decrease in financial burden on the health care system of the country, as well as the patients and a reduction in patient exposure to both medications, resulting in decreased treatment related adverse effects. In addition a larger number of patients will be able to afford the treatment due to a decrease in treatment duration and in turn the overall cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 16 weeks Interferon Tiw with Ribavirin16 weeks Interferon Tiw with Ribavirin |
| 2 | Active comparator | Drug: 24 weeks Interferon24 weeks Interferon Tiw with Ribavirin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult males and non-pregnant females (more than 18 and less than equal to 50 years of age).
- Treatment naïve patients.
- Serological evidence of hepatitis C infection by an anti-HCV antibody test
- HCV PCR positive
- Genotype 3
Key exclusion criteria (12 listed)
- Patients who do not consent to be included in the study.
- Pregnant or breast feeding females.
- Patients with a hemoglobin of <10g/dl, ANC <1500c/mm, and a platelet count <90000c/mm.
- Genotype non 3
- HCV PCR positive at the end of 4 weeks of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16 weeks Interferon Tiw with RibavirinAlso: Uniferon16 weeks Interferon Tiw | Drug | 1 |
| 24 weeks InterferonAlso: Uniferon24 weeks Interferon Tiw with Ribavirin | Drug | 2 |
Primary outcome
Sustained Virological response
Time frame: six months after stopping treatment
1 secondary outcome
Safety of short course of Interferon & Ribavirin
Time frame: Four or Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saeed S Hamid, FRCP principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 16 weeks Interferon Tiw with Ribavirin and 24 weeks Interferon in people with Hepatitis C and Chronic Disease, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological response (time frame: six months after stopping treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2008.